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Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLC

This study has been terminated.
(Study was terminated due to slow accrual)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00960297
First received: August 13, 2009
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

The rationale for this multicenter, phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (> 4.0 cm), II, and select stage III NSCLC. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Carboplatin
Drug: Paclitaxel
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • To Assess 3-year Overall Survival in Patients With Stage IB (>4.0 cm), II, or Select Stage III NSCLC Treated With Preoperative Carboplatin, Paclitaxel, and Bevacizumab Followed by Surgical Resection. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To Assess Clinical & Pathologic Response Rate, Complete Resection Rate, Toxicity, Progression-free Survival, & Overall Survival. [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: August 2009
Study Completion Date: May 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carboplatin/Paclitaxel/Bevacizumab
Preoperative chemotherapy and bevacizumab
Drug: Carboplatin
Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64
Other Name: Paraplatin
Drug: Paclitaxel
Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
Other Name: Taxol
Drug: Bevacizumab
Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
Other Name: Avastin

Detailed Description:

Adjuvant chemotherapy for patients with completely resected stage II and select stage III NSCLC is considered standard therapy. At least three large, prospective randomized trials have proven the benefit of adjuvant chemotherapy in improving survival in these patients (with a magnitude of benefit ranging from 4-12%). However, in patients who are not considered to be candidates for up-front complete resection, preoperative therapy may be indicated. Many of these patients will subsequently be eligible for resection (bimodality therapy). The rationale for this multicenter, Phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (>4.0 cm), II, and select stage III NSCLC. This trial will be conducted by the Sarah Cannon Research Institute Oncology Research Consortium. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >=18 years.
  2. Histologically-confirmed NSCLC (adenocarcinoma, large cell, and undifferentiated). Patients with squamous histology are not eligible.
  3. Life expectancy of at least 12 weeks.
  4. Patients with the following stages of NSCLC:

    • T2 N0 tumors: Limited to tumors >=4 cm.
    • T1-2 N1 tumors.
    • T3 N0-1 tumors (excluding superior sulcus tumors): Including tumors involving the chest wall, proximal airway, or mediastinal pleura where preoperative RT is not planned.
    • T1-2 N2 tumors: For patients with N2 disease involving 1 zone (Upper zone (R), AP zone (L), subcarinal zone, or lower zone) and nodes <=2 cm in diameter.
    • T4 N0-1 tumors (excluding superior sulcus tumors): T4 lesions, other than malignant effusions where radiotherapy is not planned.
  5. Patients with clinical N2 involvement must have histologic confirmation by mediastinoscopy (or alternate biopsy procedure).
  6. Tumors should be considered potentially resectable.
  7. No evidence of extrathoracic metastatic disease.
  8. Patients must have measurable disease by RECIST version 1.1 criteria.
  9. Patients must be candidates (medically) for chemotherapy followed by surgical resection.
  10. Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery (with the exception of portacath or other central access catheter placement); at least 4 weeks must have elapsed from the time of a major surgery.
  11. Laboratory values as follows:

    • Absolute neutrophil count (ANC) >=1500/µL
    • Hemoglobin (Hgb) >=9 g/dL
    • Platelets >=100,000/uL
    • AST/SGOT and ALT/SGPT within normal limits (WNL)
    • Total bilirubin within normal limits (WNL)
    • Creatinine <=1.5 mg/dL
  12. ECOG Performance Status grade 0 or 1.
  13. Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  14. Patient must be accessible for treatment and follow-up.
  15. Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.

Exclusion Criteria:

  1. Mixed small-cell and non-small cell histologies.
  2. Pulmonary carcinoid tumors.
  3. History of prior malignancy within 3 years, with the exception of non-melanoma skin cancer or carcinoma in situ.
  4. Peripheral neuropathy >= grade 1.
  5. Patients receiving thrombolytic therapy within 10 days of starting study treatment are ineligible. Therapeutic anticoagulation is allowed if the anticoagulant dosing is stable.
  6. History of acute myocardial infarction or unstable angina within 6 months prior to Day 1 of study treatment.
  7. History of or stroke or ischemic attack within 6 months prior to Day 1 of study treatment.
  8. Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) in spite of medical management.
  9. New York Heart Association (NYHA) class II or greater congestive heart failure (CHF).
  10. Patients with significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of study treatment.
  11. Any prior history of hypertensive crisis or hypertensive encephalopathy.
  12. Patients with hematemesis or hemoptysis (>=1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 of study treatment.
  13. Proteinuria at screening, as demonstrated by either:

    • Urine protein: creatinine (UPC) ratio >=1.0 (see Appendix A) at screening, or
    • Urine dipstick for proteinuria >=2+ (patients discovered to have >=2+ proteinuria on dipstick analysis should undergo a 24-hour urine collection and must have <=1g of protein in 24 hours to be eligible).
  14. Patients with a serious non-healing wound, active ulcer, or untreated bone fracture.
  15. Patients with evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
  16. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1 of study treatment.
  17. Women who are pregnant (positive pregnancy test) or lactating.
  18. Use of any non-approved or investigational agent within 28 days of administration of the first dose of study drug.
  19. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
  20. Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  21. History of hypersensitivity to active or inactive excipients of any component of treatment.
  22. Inability to comply with study and/or follow-up procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960297

Locations
United States, Florida
Holy Cross Hospital
Ft. Lauderdale, Florida, United States, 33308
United States, Indiana
Providence Medical Group
Terre Haute, Indiana, United States, 47802
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
United States, Michigan
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, New Hampshire
Portsmouth Regional Hospital
Portsmouth, New Hampshire, United States, 03801
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Investigators
Study Chair: David R Spigel, M.D. SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00960297     History of Changes
Other Study ID Numbers: SCRI LUN 144
Study First Received: August 13, 2009
Results First Received: August 27, 2013
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
Non-Small Cell Lung Cancer
NSCLC
Preoperative chemotherapy
Bevacizumab
Avastin

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Carboplatin
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014